Compounded Remdesivir (Veklury) Products are Risky

Because it is challenging to formulate remdesivir (Veklury) as a stable drug, the U.S. FDA stated it is concerned that compounded remdesivir products could be of low quality, potentially resulting in patient harm. Furthermore, the FDA announced on February 4, 2021, that heightened interest in remdesivir due to its use in COVID-19 patients might increase the risk that a substandard or counterfeit API is sold to compounders.

Given these risks, FDA cautions against compounding remdesivir drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Furthermore, the FDA says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.